Associate Study Start-up Manager, Chile

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- Our team is looking for an experienced professional with site activation, amendment, and lead experience. This person should have hands-on experience activating sites in the LATAM region as well as North America. In addition, the applicant should demonstrate at least 2 years of leadership experience._
- English proficiency both in writing and verbal communications is required. Please submit a resume in English._

BASIC FUNCTIONS:
The Associate SSU Manager is responsible for providing management of start-up activities for designated tasks within defined projects. This includes but not limited to acting in the following positions:

- Amendment lead

An ASSUM will be assigned to the study when the study is over 80% activated in all countries (described in SSU Plan) The ASSUM will remain on the study until the end of Trial and will be responsible for all Maintenance activities
- Junior SSUM

The ASSUM can be assigned onto projects in the start up phase to support the SSUM with a defined list of responsibilities or to support a 1-2 country study outside of North America. May also be assigned to support North America only studies, as applicable.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Amendment Lead

When allocated as an amendment lead the ASSUM will be responsible for, at a minimum, the following activities:

- Oversight of the planning, submissions and approval stage of protocol amendments during the maintenance phase of the study
- Updating the Amendment Addendum in the Study Start-Up (SSU) Plan or create the Amendment Plan for those studies without a SSU plan
- Oversight for the Ethics Submission approval processes (including, but not limited to timeline management, ensuring core documents are received timely, Site Contract Amendments etc, if required according to the SSU /amendment Plan
- Collaboration with relevant stakeholders e.g PM, Regulatory, Site Contracts, CTM and LSSUS throughout the process to ensure all timelines are met and all work is completed in accordance with relevant SOPs/ WPs..
- Maintain and manage SSU data tracking entries in relevant databases. Review for completeness and accuracy.
- Preparing and providing reports to study management as appropriate

Junior SSUM

When assigned in the position of a Junior SSUM the ASSUM can assume responsibility for the following activities, the exact scope of role will be determined at the start of each allocation in collaboration with the Line Manager and/or SSUM, as applicable. The ASSUM may support projects independently or as support to a SSUM.
- Lead SSU team or service line in all activities during start-up phase. Monitor team efficiency, quality and adherence to project timelines, budget, SOPs and WPs.
- Develops, with the input of regulatory and contracts, a study specific SSU plan.
- Communicates overall site activation status to internal teams and sponsor.
- Directs the process for the selection of study sites and investigators. Attend project meetings with cross functional department leads to provide strategy for identifying potential investigators.
- Works with sponsors and internal team members to establish regulatory requirements and contracts necessary for start-up.
- Where applicable, provide work instructions to team members in preparation of regulatory submissions.
- Establishes processes for the collection and initial review of regulatory packets and site contracts for investigator sites.
- Facilitates communication with the clinical team (e.g., SSU Specialist, Project Managers, Clinical, Regulatory Affairs, Vendors, and Contracts Department) during site start up, closely monitoring to ensure site activation timelines are met.
- Directs the development of study start up review plans. Assures team members incorporate required elements of the Regulatory Plan and Monitoring Plan in accordance with Good Clinical Practices (GCP).
- Prepare and QC study start-up data reporting to internal teams and/or Sponsors. This could include InfoStart reports, SAPT reporting, reporting on country / site status.
- Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
- Developing appropriate early warning systems of potential obstacles to the successful completion of study start-up; analyzes information and develops innovative solutions to challenges
- Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for addressing/mitigating risks/gaps.
- Reviewing and identifying project study trends and proactively responding to client and respective team me